Guangzhou Wondfo Biotech Co., Ltd.

No. 8 Lizhishan Road, Science City, Luogang District, 510663,

Guangzhou, P.R. China
Tel: 86-20-32296083 Fax: 86-20-32296063
Website: www.wondfo.com.cn E-mail: sales@wondfo.com.cn

CERTIFICATE OF ANALYSIS

PRODUCT: Finecare™ Lp-PLA2 Rapid Quantitative Test

Catalog No: W242
LOT. NO.： F24216102 A
EXP. ： 2024/04/21
Characterization: The FinecareTM LP-PLA2 Rapid Quantitative Test is a fluorescence
immunoassay used along with FinecareTM FlA System (Model No.: FS-
112/FS-113/FS-205) for quantitative determination of Lp-PLA2 in human
serum, plasma or whole blood. The test is used as an aid to the assessment
of the coronary heart disease (CHD) and ischemic stroke. For in vitro
diagnostic use only. For professional use only.

Performance: The FinecareTM LP-PLA2 Rapid Quantitative Test is based fluoresence

immunoassay technology . It uses a competitive immunodetection method.
When sample is added into the sample well of the Test Cartridge, the
fluorescence-labeled detector Lp-PLA2 antibodies bind to LP-PLA2 antigens
in blood specimen and form immune complexes . As the complexes migrate
on the nitrocellulose matrix by capillary action, it is captured by LP-PLA2
antigens that have been immobilized on test stip. Thus the more LP-PLA2
in blood ,the more bound fluorescence-labeled antibodies accumulated on
test strip .Signal intensity of detector LP-PLA2 antibodies reflect the amount
of antigens and are processed in the FinecareTM FlA System to determine
the LP-PLA2 concentration in blood.

Package: Packaging procedure strictly follows the production manual and packaging
control is carried out by the quality control system. Inner package: Sealed
pouch contains 1 test. Outer package: kit size of outer package is variable.

Expiry: The device is stable for 24 months from the manufactured date.

Storage: The buffer and test cartridge should be stored at temperature of 4～30℃.

Precaution: The product is offered without warranty for any other specific use than that
specified in the instruction of use.

Product approved and released based on information gained from manufacturer by:

Quality Manager
Guangzhou Wondfo Biotech Co., Ltd.